Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation

Sponsor

Diana Speelman (Other)

Overall Status

Completed

CT.gov ID

NCT05190731

Collaborator

(none)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

By measuring specific electrical parameters at acupuncture points that have been shown to correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has any influence on the bioelectric properties of the acupuncture meridian system, and 2) determine if CV4 affects the ANS.

Condition or Disease	Intervention/Treatment	Phase
Autonomic Imbalance	Other: Osteopathic cranial manipulative medicine Other: Sham	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants randomized to sham group or osteopathic cranial manipulative medicine treatment groupParticipants randomized to sham group or osteopathic cranial manipulative medicine treatment group

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Alterations in Bioelectric Activity at Acupuncture Ting (Jing-Well) Points Following CV4 Cranial Manipulation

Actual Study Start Date :

Nov 10, 2017

Actual Primary Completion Date :

Jun 24, 2018

Actual Study Completion Date :

Nov 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Each subject was treated with Sham by CSPOMM and NMM board-certified osteopathic physicians. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures.	Other: Sham Touch only, no osteopathic cranial manipulation
Active Comparator: Osteopathic cranial manipulative medicine Each subject was treated with CV4 technique by CSPOMM and NMM board-certified osteopathic physicians. All CV4 treatments were performed by one individual according to standardized protocol. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. Inherent primary respiratory mechanism motion was identified and thenar eminences followed occipital motion into the extension phase until a still point was attained. This position was held until the still point released (usually about 3 minutes) and normal cranial motion ensued	Other: Osteopathic cranial manipulative medicine Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique

Arm

Intervention/Treatment

Sham Comparator: Sham

Each subject was treated with Sham by CSPOMM and NMM board-certified osteopathic physicians. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures.

Other: Sham

Touch only, no osteopathic cranial manipulation

Active Comparator: Osteopathic cranial manipulative medicine

Each subject was treated with CV4 technique by CSPOMM and NMM board-certified osteopathic physicians. All CV4 treatments were performed by one individual according to standardized protocol. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. Inherent primary respiratory mechanism motion was identified and thenar eminences followed occipital motion into the extension phase until a still point was attained. This position was held until the still point released (usually about 3 minutes) and normal cranial motion ensued

Other: Osteopathic cranial manipulative medicine

Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique

Outcome Measures

Primary Outcome Measures

Autonomic Nervous System Activity at Acupuncture Ting Points [Within 15 minutes of sham or intervention]
Bioelectric skin conductance at acupuncture points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Eighty males and females from the Erie, PA, area aged 18-78 years, were recruited by local flyers and direct or phone contact. Participants were immediately assigned an appointment date and time. Electronic and physical copies of informed consent were provided upon arrival. Medical history questions related to exclusion criteria were then asked verbally and recorded.

Exclusion Criteria:

Eighty males and females from the Erie, PA, area aged 18-78 years, were recruited by local flyers and direct or phone contact. Participants were immediately assigned an appointment date and time. Electronic and physical copies of informed consent were provided upon arrival. Medical history questions related to exclusion criteria were then asked verbally and recorded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LECOM Health	Erie	Pennsylvania	United States	16509

Sponsors and Collaborators

Diana Speelman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diana Speelman, Director of Research, Lake Erie College of Osteopathic Medicine

ClinicalTrials.gov Identifier:

NCT05190731

Other Study ID Numbers:

24-177

First Posted:

Jan 13, 2022

Last Update Posted:

Jan 13, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 13, 2022